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The Effect of Chiropractic Treatment of Infantile Colic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02595515
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Research Unit of General Practice, Odense
Information provided by (Responsible Party):
Nordic Institute of Chiropractic and Clinical Biomechanics

Study Description
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Brief Summary:

Infantile colic is condition that affects more than 10% of babies and their families. The reason, and hence proper treatment, for this condition is unknown and many causes have been suggested. One of the treatments that parents choose is chiropractic manipulation. In Denmark, almost 10,000 babies are each year treated by chiropractors, and a high proportion is due to colic. However, the effect of chiropractic treatment of infantile colic has not been properly scientifically evaluated.

The effects of chiropractic treatment on infantile colic needs to be investigated, since this is a very common disorder with no known effective treatment, but with good empirical evidence of the value of chiropractic treatment. Although it is usually considered to be a benign and self-limiting condition, some studies suggest there might be long-term effects in terms of psychomotor problems. In worst case, the infants' crying may also lead to violence and 'shaken baby syndrome'.

Null hypothesis: There is no effect of chiropractic treatment on the course of infantile colic.

This study is a controlled, clinical trial where infants fulfilling the diagnostic criteria for colic will be randomized into two groups. One group will receive treatment and the other won't. This will determine the overall effect and furthermore, subgroup analyses will be performed to identify possible subgroups of infants, who will benefit the most from the treatment.


Condition or disease Intervention/treatment Phase
Infantile Colic Other: Chiropractic treatment Other: Visit without active treatment Not Applicable

Detailed Description:

OBJECTIVES:

Primary: To investigate the effect of chiropractic treatment on infantile colic

Secondary: to investigate if infants with suspected musculoskeletal problems respond differently to the treatment than those without.

METHOD:

A randomized controlled single blind multicenter clinical trial

The project is to be carried out on the island of Funen, Denmark. Recruitment of babies with symptoms of infantile colic is based on contact by the parents of the babies to the project manager. Information about the existence of the study is given to health visitors, general practitioners, midwifes and to women who have given birth on the maternity ward in the University Hospital of Odense. For infants fulfilling the diagnostic criteria for colic the parents will register amount of crying using a valid instrument for at least three days before the first visit at the chiropractor Clinic (baseline registration). The babies will be randomized to chiropractic treatment or no treatment. The parents will be unaware of the child's allocation. All children have four visits during two weeks at the chiropractor. All children will be taken to the chiropractor's treatment room, while the parents stay in the reception areas. Before treatment, the chiropractors will note, whether they suspect musculoskeletal involvement or not. The parents register the amount of crying continuously during the two weeks and up to and including three days after the fourth visit. Three days after the the fourth visit, the parents are informed by the chiropractor about the child's allocation. Children in the control group will afterwards have the opportunity to have four free visits with chiropractic treatment.

The parents will be asked to give consent that the medical journal regarding pregnancy and birth is reviewed in order to obtain information on specific measures (e.g. duration of pregnancy, duration of labor, delivery presentation, vacuum extractor delivery or caesarean section). Subgroup analyses will be performed to investigate associations with symptoms of colic and suspected musculoskeletal involvement. All analyses will be adjusted for known confounders, registered by the project manager at baseline.

PERSPECTIVE FOR HEALTHCARE:

First of all, the study will evaluate the effect of chiropractic treatment of infantile colic. Secondly, it will clarify if the treatment effect differs between children with suspected musculoskeletal involvement and those without.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Chiropractic Treatment of Infantile Colic. A Randomized, Controlled Trial
Study Start Date : November 2015
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic

Arms and Interventions
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Arm Intervention/treatment
Experimental: Chiropractic treatment
Manipulation and/or mobilisation. Intervention: Procedure: Chiropractic treatment.
 Other: Chiropractic treatment
Procedure: chiropractic treatment.
Other Names:
  • Manipulation
  • mobilisation
Placebo Comparator: Visit without active treatment
The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether the treatment is delivered or not.
 Other: Visit without active treatment
Procedure: Visit without active treatment. The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether the treatment is delivered or not.


Outcome Measures
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Primary Outcome Measures :
  1. Change in hours of crying [ Time Frame: Two weeks ]
    Change in number of crying hours per day based on parental diaries (before and after treatment) when comparing treated and not treated children


Secondary Outcome Measures :
  1. Change in hours of crying for children with suspected musculo-skeletal problems [ Time Frame: Two weeks ]
    Subgroup analysis for the children with suspected musculo-skeletal problems including change in number of crying hours per day based on parental diaries (before and after treatment) when comparing treated and not treated children


Eligibility Criteria
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Ages Eligible for Study:   2 Weeks to 14 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 2-14 weeks.
  • Minimum crying and fussing: three hours per day, three days per week
  • Satisfying weight gain

Exclusion Criteria:

  • Known disease
  • Symptoms than can indicate other condition than infantile colic
  • Contraindications for chiropractic treatment
  • Previous chiropractic treatment due to infantile colic
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595515


Locations
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Denmark
University of Southern Denmark
Odense, Denmark, 5230
Sponsors and Collaborators
Nordic Institute of Chiropractic and Clinical Biomechanics
Research Unit of General Practice, Odense
Investigators
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Principal Investigator: Lise V Holm, MD, PhD Research Unit of General Practice, Odense, University of Southern Denmark, JB Wilsløwsvej 9A, 5000 Odense C, Denmark
Study Director: Lise Hestbæk, Assoc Prof Nordic Institute of Chiropractic and Clinical Biomechanics. Campusvej 55, 5250 Odense M, DK, Denmark
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nordic Institute of Chiropractic and Clinical Biomechanics
ClinicalTrials.gov Identifier: NCT02595515    
Other Study ID Numbers: -14/1206
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Colic
Infant, Newborn, Diseases